US20130158653A1 - Medical device delivery systems - Google Patents
Medical device delivery systems Download PDFInfo
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- US20130158653A1 US20130158653A1 US13/714,860 US201213714860A US2013158653A1 US 20130158653 A1 US20130158653 A1 US 20130158653A1 US 201213714860 A US201213714860 A US 201213714860A US 2013158653 A1 US2013158653 A1 US 2013158653A1
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- United States
- Prior art keywords
- outer sheath
- inner catheter
- tube extension
- configuration
- distal end
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/2436—Deployment by retracting a sheath
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0057—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof stretchable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
- A61M25/0012—Making of catheters or other medical or surgical tubes with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F04—POSITIVE - DISPLACEMENT MACHINES FOR LIQUIDS; PUMPS FOR LIQUIDS OR ELASTIC FLUIDS
- F04C—ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT MACHINES FOR LIQUIDS; ROTARY-PISTON, OR OSCILLATING-PISTON, POSITIVE-DISPLACEMENT PUMPS
- F04C2270/00—Control; Monitoring or safety arrangements
- F04C2270/04—Force
- F04C2270/042—Force radial
- F04C2270/0421—Controlled or regulated
Definitions
- the present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical devices for delivering a replacement heart valve.
- intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
- An example medical device delivery system may include an outer sheath.
- An inner catheter may be disposed within the outer sheath.
- the inner catheter may have a distal end.
- a tube extension may be coupled to the distal end of the inner catheter and may extend distally therefrom.
- the tube extension may be configured to shift between a first elongated configuration and a second shortened configuration.
- Another example medical device delivery system may include an outer sheath.
- An inner catheter may be disposed within the outer sheath.
- the inner catheter may have a distal portion.
- a valve implant may be releasably coupled to the distal portion of the inner catheter.
- a tube extension may be coupled to the distal portion of the inner catheter and may extend distally therefrom. The tube extension may have a distal end that is free of a nose cone.
- Another example medical device delivery system may include an outer sheath having a distal portion.
- the distal portion may be configured to shift between a tapered configuration where the distal portion is deflected radially inward and an open configuration.
- An inner catheter may be disposed within the outer sheath.
- the inner catheter may have a distal end.
- a valve implant may be releasably coupled to the distal end of the inner catheter.
- FIG. 1 is side view of an example medical device system
- FIG. 2 is a cross-sectional side view of an example outer sheath
- FIG. 3 is a transverse cross-sectional view taken through line 3 - 3 in FIG. 2 ;
- FIG. 3A is a transverse cross-sectional view taken through line 3 - 3 in FIG. 2 ;
- FIG. 4 is a side view of an example inner catheter
- FIG. 5 is a cross-sectional view taken through line 5 - 5 in FIG. 4 ;
- FIG. 6 is a cross-sectional view taken through line 6 - 6 in FIG. 4 ;
- FIG. 7 is a perspective view of a portion of an example implant associated with the example medical device system
- FIGS. 8-11 are perspective views that illustrate an example mechanism for locking an implant
- FIG. 12 is a side view of a portion of an example sheathing aid
- FIG. 13 is an enlarged plan view illustrating engagement of the example sheathing aid with an example implant
- FIG. 14 is a side view of an example handle
- FIG. 15 is a cut away view illustrating some of the interior components of the example handle
- FIGS. 16-18 illustrate an example of coordinated movement of handle components within the example handle
- FIGS. 19-20 illustrate the rotation of a collar on the example handle
- FIGS. 21-22 illustrate some of the components within the example handle during rotation of the collar
- FIG. 23 is a partial cross-section side view of an example tube extension for use with a medical device delivery system
- FIG. 24 is a partial cross-section side view of the example tube extension shown in FIG. 23 where the tube extension is in a partially shortened configuration
- FIG. 25 is a partial cross-section side view of the example tube extension in FIG. 23 where the tube extension is in a further shortened configuration
- FIG. 26 is a partial cross-section side view of another example tube extension for use with a medical device delivery system
- FIG. 27 is a partial cross-section side view of the example tube extension shown in FIG. 26 where the tube extension is in a shortened configuration
- FIG. 28 is a side view of another example tube extension for use with a medical device delivery system
- FIG. 29 is a partial cross-section side view of another example tube extension for use with a medical device delivery system
- FIG. 30 is a partial cross-section side view of the example tube extension shown in FIG. 29 where the tube extension is in a shortened configuration
- FIG. 31 is a side view of a portion of an example sheath for use with a medical device delivery system in a first configuration
- FIG. 32 is a side view of a portion of the example sheath shown in FIG. 31 in a second configuration.
- Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart.
- failure of the aortic valve can have a serious effect on a human and could lead to serious health condition and/or death if not dealt with.
- Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve.
- Such therapies may be highly invasive to the patient.
- medical devices that may be used for delivering a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system.
- At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve).
- the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient.
- the devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below.
- FIG. 1 is a side view of an example medical device system 10 . It should be noted that some features of system 10 are either not shown, or are shown schematically, in FIG. 1 for simplicity. Additional details regarding some of the components of system 10 are provided in other figures in greater detail.
- System 10 may be used to deliver and/or deploy a variety of medical devices to a number of locations within the anatomy.
- system 10 is a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a replacement heart valve. This, however, is not intended to be limiting as system 10 may also be used for other interventions including mitral, tricuspid, or pulmonary valve replacement, valve repair, valvuloplasty, and the like, or other similar interventions.
- System 10 may generally be described as a catheter system that includes an outer sheath or catheter 12 and an inner catheter or tube 14 (a portion of which is shown in FIG. 1 in phantom line) extending at least partially through outer sheath 12 .
- a medical device implant 16 may be coupled to inner catheter 14 and disposed within outer sheath 12 during delivery of implant 16 .
- a handle 18 may be disposed at the proximal end of outer sheath 12 and inner catheter 14 . In general, handle 18 may be configured to manipulate the position of outer sheath 12 relative to inner catheter 14 as well as aid in the deployment of implant 16 .
- system 10 may be advanced percutaneously through the vasculature to a position adjacent to an area of interest.
- system 10 may be advanced through the vasculature to a position adjacent to a defective aortic valve.
- implant 16 may be generally disposed in an elongated and low profile “delivery” configuration within outer sheath 12 .
- outer sheath 12 may be refracted to expose implant 16 .
- Implant 16 may be actuated in order to expand implant into a generally shortened and larger profile “deployed” configuration suitable for implantation within the anatomy.
- system 10 can be removed from the vasculature, leaving implant 16 in place to function as, for example, a suitable replacement for the native aortic valve.
- implant 16 may be deployed within the native valve (e.g., the native valve is left in place and not excised). Alternatively, the native valve may be removed and implant 16 may be deployed in its place as a replacement.
- FIGS. 2-13 illustrate some of the components of system 10 .
- FIG. 2 is a cross-sectional side view of outer sheath 12 .
- outer sheath 12 has a proximal portion 20 and a distal portion 22 .
- Distal portion 22 may have a slightly enlarged or flared inner diameter, which may provide additional space for holding implant 16 therein.
- the inner diameter of outer sheath 12 along proximal portion 20 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.56388 ⁇ 0.0508 cm (0.222 ⁇ 0.002 inches).
- the inner diameter of outer sheath 12 along distal portion 22 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.579 to 0.5842 cm (0.228 to 0.230 inches).
- distal tip 24 At the distal end of distal portion 22 may be a distal tip 24 , which may be flared or otherwise have a funnel-like shape.
- the funnel-like shape increases the outer diameter (and inner diameter) of outer sheath 12 at distal tip 24 and may aid in the sheathing and/or resheathing of implant 16 into outer sheath 12 .
- outer sheath 12 may have a generally constant outer diameter.
- outer sheath 12 may have an outer diameter in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.6858 cm (0.270 inches).
- outer sheath 12 may also have a length that is appropriate for reaching the intended area of interest within the anatomy. For example, outer sheath 12 may have a length in the range of about 30 to 200 cm, or about 60 to 150 cm, or about 100 to 120 cm, or about 108 ⁇ 0.20 cm. Outer sheath 12 may also be curved.
- a distal section of outer sheath 12 may be curved.
- the radius of the curve (measured from the center of outer sheath 12 ) may be in the range of about 2 to 6 cm (20 to 60 mm), or about 3 to 4 cm (30 to 40 mm), or about 3.675 cm (36.75 mm). Again, these dimensions are examples and are not intended to be limiting.
- Outer sheath 12 may be formed from a singular monolithic tube or unitary member. Alternatively, outer sheath 12 may include a plurality of layers or portions. One or more of these layers may include a reinforcing structure such as a braid, coil, mesh, combinations thereof, or the like.
- FIG. 3 illustrates one example of a multilayer structure for outer sheath 12 .
- outer sheath 12 may include an inner liner or layer 26 .
- An intermediate or tier layer 28 may be disposed on inner liner 26 .
- a reinforcement 30 may be disposed on intermediate layer 28 .
- a topcoat or outer layer 32 may be disposed on reinforcement 30 .
- an outer coating 34 (e.g., a lubricious coating, a hydrophilic coating, a hydrophobic coating, etc.) may be disposed along portions or all of topcoat 32 .
- outer sheath 12 including embodiments including two or more layers that may be different from those shown in FIG. 3 , embodiments without a reinforcement, and the like, or other suitable configurations.
- inner liner 26 may include a polymeric material, preferably having a low coefficient of friction, such as fluorinated ethylene propylene (FEP) and may have a thickness in the range of about 0.00254 to 0.0127 cm (0.001 to 0.005 inches) or about 0.00762 ⁇ 0.00254 (0.003 ⁇ 0.001 inches)
- intermediate layer 28 may include a polymer material such as polyether block amide (e.g., PEBAX 6333) and may have a thickness in the range of about 0.00254 to 0.0127 cm (0.001 to 0.005 inches) or about 0.00508 ⁇ 0.00254 (0.002 ⁇ 0.001 inches)
- outer coating 34 may include a polymer material such as polyether block amide (e.g., PEBAX 7233) and may have a thickness in the range of about 0.00254 to 0.0254 cm (0.001 to 0.01 inches).
- outer coating 34 may vary in thickness. For example, along proximal portion 20 outer coating 34 may have greater thickness, such as about 0.0127 to about 0.0508 cm or about 0.02159 cm (0.005 to 0.02 inches or about 0.0085 inches), than along distal portion 22 and/or distal tip 24 , which may be about 0.0127 to about 0.0508 cm or about 0.01651 cm (e.g., about 0.005 to 0.02 inches or about 0.0065 inches). These are just examples as other suitable materials may be used.
- distal tip 24 may also vary.
- inner liner 26 i.e., a 2.5 mm section thereof
- outer sheath 12 e.g., around reinforcement 30 and topcoat 32
- a ring member (not shown) made from a suitable material such as a 55D polyether block amide (e.g., 55D PEBAX) may be disposed over inner liner 26 and heat bonded to form distal tip 24 . This may form the funnel-like shape of distal tip 24 .
- Reinforcement 30 may also vary in form.
- reinforcement 30 may take the form of a braid, coil, mesh, or the like.
- reinforcement 30 may include a metallic braid (e.g., stainless steel).
- reinforcement 30 may also include additional structures such as one or more longitudinally-extending strands.
- reinforcement 30 may include a pair of longitudinally-extending aramid and/or para aramid strands 31 (for example, KEVLAR®) disposed on opposite sides of the braid, as seen in FIG. 3A .
- the strands 31 may or may not be woven into portions or all of the braid.
- FIG. 4 is a side view of the inner catheter 14 .
- a distal end region of inner catheter 14 may include a step in outer diameter 40 that defines a decreased outer diameter section 42 .
- decreased outer diameter section 42 may have an outer diameter in the range of about 0.127 to 0.635 cm (0.05 to 0.25 inches), or about 0.254 to 0.508 cm (0.10 to 0.20 inches), or about 0.38608 ⁇ 0.00762 (0.152 ⁇ 0.003 inches) as opposed to the remainder of inner catheter 14 where the outer diameter may be in the range of about 0.127 to 0.762 cm (0.05 to 0.30 inches), or about 0.254 to 0.635 cm (0.10 to 0.25 inches), or about 0.508 ⁇ 0.0254 cm (0.20 ⁇ 0.01 inches).
- Decreased outer diameter section 42 may define a region where other components of system 10 may be attached. Some additional details regarding these components can be found herein.
- inner catheter 14 may take the form of an extruded polymer tube.
- inner catheter 14 is a singular monolithic or unitary member. In other embodiments, inner catheter 14 may include a plurality of portions or segments that are coupled together. The total length of inner catheter may be in the range of about 60 to 150 cm, or about 80 to 120 cm, or about 100 to 115 cm, or about 112 ⁇ 0.02 cm. Just like outer sheath 12 , inner catheter 14 may also be curved, for example adjacent to the distal end thereof. In some embodiments, inner catheter 14 may have one or more sections with a differing hardness/stiffness (e.g., differing shore durometer).
- inner catheter may have a proximal region 44 a and an intermediate region 44 b .
- Proximal region 44 a may include a generally stiff polymeric material such as a 72D polyether block amide (e.g., 72D PEBAX) and may have a length in the range of about 60 to 150 cm, or about 80 to 120 cm, or about 100 to 115 cm, or about 109.5 ⁇ 0.02 cm.
- Intermediate region 44 b may include a 40D polyether block amide (e.g., 40D PEBAX) and may have a length in the range of about 5 to 25 mm, or about 10 to 20 mm, or about 15 ⁇ 0.01 mm.
- Section 42 may also differ from regions 44 a / 44 b and, in some embodiments, may include a 72D polyether block amide (e.g., 72D PEBAX) and may have a length in the range of about 0.5 to 2 cm (5 to 20 mm), or about 0.8 to 1.5 cm (8 to 15 mm), or about 1 ⁇ 0.001 cm (10 ⁇ 0.01 mm). These are just examples.
- 72D PEBAX 72D polyether block amide
- Inner catheter 14 may include one or more lumens.
- FIG. 5 which is a cross sectional view of inner catheter 14 adjacent to proximal end portion 36 ) illustrates that inner catheter 14 may include a first lumen 46 , a second lumen 48 , a third lumen 50 , and a fourth lumen 52 .
- lumens 46 / 48 / 50 / 52 extend along the entire length of inner catheter 14 .
- Other embodiments are contemplated, however, where one or more of lumens 46 / 48 / 50 / 52 extend along only a portion of the length of inner catheter 14 .
- fourth lumen 52 may stop just short of the distal end of inner catheter 14 and/or be filled in at its distal end to effectively end fourth lumen 52 proximal of the distal end of inner catheter 14 , as illustrated in FIG. 6 by the absence of fourth lumen 52 adjacent to the distal end of inner catheter 14 .
- first lumen 46 Disposed within first lumen 46 may be push-pull rods 84 (not shown in FIG. 5 , seen in other figures including FIG. 7 ), which are used to expand and/or elongate implant 16 as explained in more detail herein.
- first lumen 46 may be lined with a low friction liner 54 (e.g., a FEP liner).
- second lumen 48 Disposed within second lumen 48 may be a pin release mandrel 92 (not shown in FIG. 5 , seen in other figures including FIG. 7 ), which is also explained in more detail herein.
- second lumen 48 may be lined with a hypotube liner 56 .
- Third lumen 50 may be a guidewire lumen and this lumen may also be lined with a hypotube liner 58 .
- Fourth lumen 52 may be used to house a non-stretch wire 60 .
- the form of non-stretch wire 60 may vary.
- non-stretch wire 60 may take the form of a stainless steel braid.
- the non-stretch wire 60 may optionally include a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides of the braid.
- non-stretch wire 60 may be embedded within fourth lumen 52 .
- non-stretch wire 60 may extend to a position adjacent to distal end portion 38 but not fully to the distal end of inner catheter 14 as illustrated in FIG. 6 by the absence of fourth lumen 52 adjacent to the distal end of inner catheter 14 .
- a short distal segment of fourth lumen 52 may be filled in with polymer material adjacent to the distal end of inner catheter 14 .
- Inner catheter 14 may also include a guidewire tube extension 62 that extends distally from distal end portion 38 .
- a nose cone 64 is attached to guidewire tube extension 62 .
- Nose cone 64 generally is designed to have an atraumatic shape.
- Nose cone 64 may also include a ridge or ledge 66 that is configured to abut the distal tip 24 of outer sheath 12 during delivery of implant 16 .
- FIG. 7 illustrates some of the additional components of system 10 and implant 16 .
- implant 16 includes a plurality of valve leaflets 68 (e.g., bovine pericardial) which are secured to a cylindrical braid 70 at a post or commissure post 72 , for example at the commissure portions of the leaflets 68 .
- implant 16 includes three leaflets 68 secured to braid 70 with three posts 72 .
- leaflets 68 may also be secured to the base or “distal end” of braid 70 .
- the posts 72 in turn, may be secured to braid 70 (e.g., along the interior of braid 70 ) with sutures or other suitable mechanisms.
- buckles 76 Positioned adjacent to (e.g., longitudinally spaced from and aligned with) posts 72 are a plurality of buckles 76 , which may also be sutured to braid 70 (e.g., along the interior of braid 70 ).
- one buckle 76 is attached to braid 70 adjacent to each of the three posts 72 .
- braid 70 has a total of three buckles 76 and three posts 72 attached thereto.
- Other embodiments are contemplated where fewer or more buckles 76 and posts 72 may be utilized.
- a seal 74 (shown in cross-section) may be disposed about braid 70 and, as the name suggests, may help to seal implant 16 within a target implant site or area of interest, thereby preventing blood leakage around the device (i.e., paravalvular regurgitation, etc.).
- Coupler 78 may generally include a cylindrical base (not shown) that is attached to inner catheter 14 (e.g., disposed about and attached to reduced outer diameter section 42 ). Projecting distally from the base are three fingers that are each configured to engage with implant 16 at posts 72 and buckles 76 . A collar 80 may further assist in holding together these structures.
- a guide 82 may be disposed over each of the fingers and may serve to keep the fingers of coupler 78 associated with push-pull rods 84 extending adjacent to coupler 78 .
- a pin release assembly 86 may be a linking structure that keeps posts 72 , buckles 76 , and push-pull rods 84 associated with one another.
- Pin release assembly 86 includes a plurality of individual pins 88 that may be joined together via a coiled connection 90 and held to a pin release mandrel 92 with a ferrule 94 .
- implant 16 is secured at the distal end of inner catheter 14 by virtue of the association of the fingers of coupler 78 being coupled with a projecting proximal end of buckles 76 (and being held in place with collar 80 disposed over the connection) and by virtue of pins 88 securing together push-pull rods 84 and posts 72 .
- outer sheath 12 may be withdrawn (e.g., moved proximally relative to inner catheter 14 ) to expose implant 16 .
- push-pull rods 84 can be used to expand and “lock” implant 16 in the expanded or deployed configuration by proximally retracting push-pull rods 84 to pull posts 72 into engagement with buckles.
- pins 88 can be removed, thereby uncoupling push-pull rods 84 from posts 72 , which allows implant 16 to be released from system 10 and deployed in the anatomy.
- FIGS. 8-11 illustrate the locking system utilized with system 10 .
- push-pull rod 84 extends through guide 82 adjacent to the fingers of coupler 78 , through collar 80 , through buckle 76 , and into a hollow t-shaped bar portion 96 of post 72 .
- the distal end of push-pull rod 84 may include an opening or aperture (not shown) that can be aligned with an opening 98 of t-shaped bar portion 96 .
- pin 88 When so aligned, pin 88 can be looped through opening 98 and the opening of push-pull rod 84 . This secures push-pull rod 84 to post 72 and forms a configuration of these structures that can be utilized during delivery of implant 16 .
- the proximal end of post 72 and the distal end of buckle 76 are longitudinally separated and, accordingly, implant 16 is in an elongated and generally low-profile configuration suitable for delivery.
- FIG. 9 illustrates push-pull rod 84 proximally retracted.
- post 72 is brought into contact with buckle 76 .
- a raised, generally transversely-oriented ridge 100 on t-shaped bar portion 96 may be pulled proximally past buckle 76 so that post 72 is secured and held in place by buckle 76 .
- pins 88 may be pulled (e.g., removed from openings 98 and the openings in push-pull rods 84 ) to uncouple push-pull rods 84 from posts 72 as shown in FIG. 10 .
- push-pull rods 84 Further retraction of push-pull rods 84 causes a longitudinally-oriented ridge 102 on push-pull rods 84 to engage collar 80 and causes collar 80 to slide proximally along the fingers of coupler 78 . In doing so, a forked end 104 of the fingers, which has a groove 106 formed therein, is exposed and can be uncoupled from a rail 108 , which has a projection 110 formed thereon that is configured to mate with groove 106 , as shown in FIG. 11 . Thereafter, system 10 can be removed from the anatomy, leaving behind the expanded and deployed implant 16 .
- FIGS. 12-13 illustrate another component that may be included with system 10 .
- FIG. 12 is a side view of a portion of a sheathing aid 112 .
- sheathing aid 112 includes a base 114 and a group of petals including a set of three longer petals 116 and a pair of shorter petals 118 .
- a group of petals 116 / 118 may be positioned between each of the fingers of coupler 78 .
- sheathing aid 112 may have a total of fifteen petals (e.g., three groups that each include three “long” petals 116 and two “short” petals 118 , with each group being positioned between adjacent pairs of fingers of coupler 78 ).
- Base 114 may be secured to inner catheter 14 adjacent to coupler 78 (e.g., underneath coupler 78 and between coupler 78 and inner catheter 14 ).
- Sheathing aid 112 may be used to aid in the sheathing of implant 16 into outer sheath 12 .
- sheathing aid 112 may aid in the initial sheathing of implant 16 (e.g., removing implant 16 from a packaging container such as a bottle and pulling implant 16 into outer sheath 12 ) and in re-sheathing implant 16 during repositioning and/or retraction of implant 16 within the area of interest.
- Sheathing may be accomplished via the arrangement and positioning of the various petals 116 / 118 .
- FIG. 13 illustrates the longer petals 116 woven in and out of braid 70 , and the shorter petals 118 disposed along the exterior of braid 70 acting as a funnel for sheathing.
- FIG. 14 is a side view of handle 18 .
- handle 18 includes a handle housing 120 .
- a rotatable control knob 122 may be disposed about handle housing 120 (e.g., at a proximal end of handle housing 120 ) and may be used to move one or more of the components of system 10 (e.g., outer sheath 12 , push-pull rods 84 , etc.).
- a rotatable collar 156 may be disposed about the handle housing 120 .
- Control knob 122 may be disposed about a proximal portion of collar 156 .
- a slidable door 124 may also be disposed about handle housing 120 .
- Door 124 may translate distally to expose a distal portion of rotatable collar 156 (not shown in FIG. 14 , can be seen in other figures including FIGS. 19-20 ) positioned generally under door 124 .
- Collar 156 may be rotated to move one or more components of system 10 (e.g., push-pull rods 84 , pin release mandrel 92 , etc.).
- Handle 18 may also include one or more apertures 129 a / 129 b and/or flush ports 126 / 128 that can be used to flush system 10 .
- distal flush port 126 and proximal flush port 128 may be accessible from the exterior of the handle housing 120 through distal aperture 129 a and proximal aperture 129 b , respectively.
- FIG. 15 is a side view of handle 18 with a portion of handle housing 120 removed, exposing at least some of the interior components.
- outer sheath 12 may be attached to a sheath adapter 130 .
- Sheath adapter 130 is attached to a sheath carriage 132 , which may be threaded onto a lead screw 134 .
- Distal flush port 126 may be disposed on sheath adapter 130 .
- distal flush port 126 provides access to the interior or lumen of outer sheath 12 (e.g., access to space between inner catheter 14 and outer sheath 12 ) so that a clinician can flush fluid through the lumen of outer sheath 12 to remove any unwanted materials (e.g., air, fluid, contaminants, etc.) therein prior to use of system 10 .
- distal flush port 126 has a luer type connector (e.g., a one-way luer connector) that allows a device such as a syringe with a corresponding connector to be attached thereto for flushing.
- inner catheter 14 Extending through and proximally from sheath adapter 130 is inner catheter 14 .
- a proximal end of inner catheter 14 is attached (e.g., fixedly attached) to an interior body or diverter 136 .
- Diverter 136 is attached to a support body 140 .
- diverter 136 and/or support body 140 may have one or more passageways or lumens formed therein.
- push-pull rods 84 and/or pin release mandrel 92 may extend through respective passageways.
- first shaft or hypotube 142 and a second shaft or hypotube 144 may extend through the passageways in diverter 136 , and in some embodiments, the first shaft or hypotube 142 extends through a first passageway and the second shaft or hypotube 144 extends through a second passageway that is separate or distinct from the first passageway.
- first shaft 142 is attached to pin release mandrel 92 .
- second shaft 144 is attached to push-pull rods 84 .
- three push-pull rods 84 are utilized.
- the three push-pull rods 84 come together (e.g., brought into contact with one another or otherwise brought into relatively close proximity with one another) adjacent to the distal end of inner catheter 14 and enter first lumen 46 .
- push-pull rods 84 may be attached to one another.
- push-pull rods 84 may be welded together about 10.16 cm (about 4.00 inches) from their distal ends.
- push-pull rods 84 may be welded together proximate their proximal ends in addition to or instead of the distal weld. Proximally thereafter, push-pull rods 84 may extend to second shaft 144 .
- a hypotube (e.g., hypotube liner 58 disposed along guidewire lumen 52 ) may extend through diverter 136 within a passageway therein and then be “diverted” around a portion of diverter 136 and support body 140 , and ultimately be extended to a position at the proximal end of handle 18 so as to provide a user access to guidewire lumen 52 .
- Proximal flush port 128 may be disposed on support body 140 that can be used to flush the lumens of inner catheter 14 and, for example, may function similarly to distal flush port 126 .
- first shaft 142 may be secured to a slider 146 and second shaft 144 may be secured to a force limiter body 150 .
- the connections between the various components may include a number of different types of connections including mechanical bonding (e.g., pinning, threading, interference fit, etc.), adhesive bonding, thermal bonding, etc.
- Slider 146 may be slidable relative to force limiter body 150 .
- Slider 146 may be selectively locked to force limiter body 150 , thereby preventing relative movement between the slider 146 and the force limiter body 150 .
- Force limiter body 150 may be secured to a push-pull rod carriage 152 , which may be threaded onto lead screw 134 .
- lead screw 134 can cause movement of push-pull rod carriage 152 and force limiter body 150 and thus, push-pull rods 84 (via second shaft 144 ).
- force limiter body 150 forms or defines a stop point that provides tactile feedback (e.g., resistance to further rotation of control knob 122 ) to the user indicating that push-pull rods 84 have been retracted proximally a sufficient distance to lock posts 72 with buckles 76 .
- tactile feedback e.g., resistance to further rotation of control knob 122
- a clinician may use an appropriate visualization technique to visualize proper locking (e.g., the relative positioning of the posts 72 and the buckles 76 ).
- a chock 148 may be positioned adjacent to slider 146 to selectively lock slider 146 to force limiter body 150 . In order to allow pin release mandrel 92 to be proximally retracted to pull pins 88 , chock 148 can be rotated or otherwise moved to a secondary position or configuration.
- chock 148 no longer forms a barrier to further movement of, for example, slider 146 and pin release mandrel 92 . Accordingly, with chock 148 no longer acting as an impediment, slider 146 and pin release mandrel 92 can be proximally retracted to facilitate deployment of implant 16 by allowing pins 88 to be pulled.
- Handle 18 also includes a rotatable ring 155 with internal teeth that are configured to engage with teeth on a gear 157 coupled to lead screw 134 .
- Ring 155 is coupled to control knob 122 so that rotation of control knob 122 results in analogous motion of ring 155 and thus lead screw 134 .
- Handle 18 is generally configured for coordinated movement of multiple structures of system 10 .
- handle 18 is configured to allow a user to move outer sheath 12 (e.g., relative to inner catheter 14 ), move push-pull rods 84 , and move pin release mandrel 92 .
- handle 18 is configured so that the appropriate structure can be moved at the appropriate time during the intervention so that implant 16 can be delivered in an efficient manner.
- Some examples of how the coordinated movement of system 10 may occur within handle 18 may be similar to those disclosed in U.S. Patent Application Pub. No. US 2010/0280495, the entire disclosure of which is herein incorporated by reference.
- handle 18 may include a lost motion barrel 158 .
- Lost motion barrel 158 is configured to engage carriages 132 / 152 and/or screws associated with carriages 132 / 152 at different times during the intervention to stop motion (e.g., create “lost motion” of the appropriate carriage).
- FIGS. 16-19 illustrate some of the coordinated motion achieved by handle 18 . It should be noted that some elements of system 10 are not shown in FIGS. 16-20 for clarity. For example, FIG. 16 illustrates a first position or state for handle 18 where outer sheath 12 is extended distally relative to inner catheter 14 (and handle 18 ) so as to fully sheath (e.g., contain) implant 16 .
- sheath carriage 132 While in this position, sheath carriage 132 is positioned adjacent to the distal end of handle 18 .
- a rod screw 152 a associated with push-pull rod carriage 152 is extended distally from push-pull rod carriage 152 and positioned within lost motion barrel 158 .
- lead screw 134 Upon rotation of control knob 122 (e.g., in the clockwise direction), lead screw 134 begins to rotate. Rotation of lead screw 134 causes sheath carriage 132 to move along lead screw 134 in the proximal direction, resulting in proximal movement of outer sheath 12 (e.g., “unsheathing” implant 16 ). This initial rotation of lead screw 134 also causes rod screw 152 a to rotate.
- rod screw 152 a may be engaged with a helical thread disposed along the interior of lost motion barrel 158 .
- rod screw 152 a is spaced from push-pull rod carriage 152 , it does not exert a force onto push-pull rod carriage 152 .
- initial motion of control knob 122 does not result in movement of push-pull rod carriage 152 and, instead, only results in translation of sheath carriage 132 and rotation (and translation) of rod screw 152 a.
- rod screw 152 a (e.g., the knob formed therein) reaches an essentially linear thread or pathway formed at the end of lost motion barrel 158 .
- the linear thread allows rod screw 152 a to translate along lead screw 134 to a position where rod screw 152 a contacts (e.g., is threaded within and abuts) push-pull rod carriage 152 .
- rod screw 152 a can contact and move proximally push-pull carriage 152 .
- further rotation of lead screw 134 not only causes sheath carriage 132 to move proximally but also causes push-pull rod carriage 152 to move proximally as shown in FIG. 17 .
- a sheath carriage screw 132 a of sheath carriage 132 enters lost motion barrel 158 as shown in FIG. 18 . This may occur in a manner similar to how rod screw 152 a threads and unthreads with the helical thread formed along lost motion barrel 158 . For example, while sheath carriage 132 is translating, sheath carriage screw 132 a may follow an essentially linear thread or pathway formed along or adjacent to lost motion barrel 158 . Upon reaching lost motion barrel 158 , sheath carriage screw 132 a (e.g., a knob or projection formed thereon) may shift into engagement with the helical thread within lost motion barrel 158 and rotate.
- sheath carriage screw 132 a e.g., a knob or projection formed thereon
- This rotation “unthreads” sheath carriage screw 132 a from sheath carriage 132 . Accordingly, additional rotation of lead screw 134 results in continued proximal movement of push-pull rod carriage 152 while motion of sheath carriage 132 ceases.
- lead screw 134 has a plurality of portions, for example a first portion 134 a and a second portion 134 b , with a differing pitch to its thread. This may allow carriages 132 / 152 to travel at different rates along lead screw 134 .
- the pitch of lead screw 134 along which sheath carriage 132 translates may be generally more spaced or slanted than at positions adjacent to push-pull rod carriage 152 .
- the coordinated movement of carriages 132 / 152 also may be configured so that sheath carriage 132 translates along lead screw 134 at a greater rate than push-pull rod carriage 152 .
- Other configurations are contemplated where the above-mentioned configuration is reversed as well as further configurations where the pitch of lead screw 134 is essentially constant or includes a number of different pitch regions.
- door 124 may be slid distally along a collar 156 (which is positioned on handle 18 ) as shown in FIG. 19 .
- Push-pull rod carriage 152 may also include a radially-extending proximal flag member 164 .
- flag member 164 may be designed as a feature that can prevent collar 156 from being rotated earlier than desired (and, thus, prevent pins 88 from being pulled earlier than desired).
- flag member 164 may be positioned within and follow a groove (not shown) along the interior of collar 156 .
- flag member 164 While positioned within the groove, flag member 164 essentially forms a physical barrier that prevents collar 156 from rotating relative to handle housing 120 .
- push-pull rod carriage 152 is translated proximally to the back of handle housing 120 (e.g., when push-pull rods 84 are proximally retracted so as to lock posts 72 with buckles 76 )
- flag member 164 exits the groove in collar 156 . Accordingly, flag member 164 no longer impedes rotation of collar 156 and, as such, collar 156 can now be rotated to pull pins 88 .
- Collar 156 via ring 154 , is associated with a gear 160 engaged with a secondary screw 162 . Notches at a proximal end of collar 156 engage protrusions on ring 154 such that rotation of collar 156 causes corresponding rotation of ring 154 and thus secondary screw 162 .
- the initial rotation of collar 156 is sufficient to rotate chock 148 (e.g., via a mechanical interaction between collar 156 and chock 148 that causes chock 148 to shift) from a first configuration where slider 146 (and, thus, pin release mandrel 92 ) is selectively locked to force limiter body 150 , to a secondary configuration, which permits slider 146 to translate along secondary screw 162 as secondary screw 162 rotates, to proximally retract and pull pins 88 (e.g., via pin release mandrel 92 ). As seen in FIG.
- chock 148 in the first configuration engages a ridge 168 along a top portion of force limiter body 150 which forms a physical barrier that prevents proximal translation of slider 146 relative to force limiter body 150 .
- collar 156 is rotated to shift chock 148 into the secondary configuration, slider 146 can translate proximally within a groove 166 disposed in the top portion of force limiter body 150 (e.g., as seen in FIG. 22 ), as collar 156 is rotated about the handle housing 120 to pull the pins 88 from the openings 98 and the openings in the distal ends of the push-pull rods 84 .
- push-pull rods 84 may be withdrawn from implant 16 , thereby deploying the implant at the target site (area of interest).
- control knob 122 may be rotated to move the sheath carriage 132 distally within the handle housing 120 , thereby moving outer sheath 12 distally relative to inner catheter 14 and three-finger coupler 78 so as to cover or re-sheath the elements of system 10 disposed at the distal end. System 10 may then be removed from the patient's anatomy.
- implant 16 is a replacement aortic valve
- implantation of implant 16 may include the positioning of at least a portion of system 10 across the native aortic valve and within the heart.
- guidewire tube extension 62 and/or nose cone 64 may be disposed within the heart. It may be possible that during an intervention, nose cone 64 , for example, could lie within the left ventricle and could interfere with or otherwise impact the functioning of the left ventricle (and/or other portions of the heart).
- FIGS. 23-25 illustrates an example guidewire tube extension 170 that is configured to shift between an elongated configuration and a shortened configuration. It should be noted that for simplicity purposes, only a portions of the delivery system are shown in FIGS. 23-25 (as well as other figures) some of the structures illustrated in these figures are shown schematically (e.g., implant 16 is shown schematically). However, it can be appreciated that the features shown in these figures can be applied to any of the delivery systems disclosed herein and/or components of delivery systems disclosed herein.
- Guidewire tube extension 170 may include a tubular body 172 that includes or otherwise takes the form of an expandable coil 174 .
- tubular body 172 may be sleeve or tube that covers coil 174 .
- tubular body 172 may be defined by coil 174 .
- guidewire tube extension 170 (as well as other guidewire tube extensions disclosed herein) may include other features of guidewire tube extension 62 such as a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides of tubular body 172 .
- Coil 174 may be biased to be in an unexpanded configuration and also be configured to expand and/or elongate in response to tensile forces. For example, as sheath 12 is advanced distally so as begin to “sheath” implant 16 , sheath 12 may contact nose cone 64 . Further advancement of sheath 12 may exert a force in the distal direction, which in turn may exert a tensile force on coil 174 . This may elongate coil 174 and open the pitch of coil 174 (e.g., where adjacent windings of coil 174 are spaced from one another).
- the delivery system (including guidewire tube extension 170 ) can be navigated through the anatomy to a position adjacent to a target location.
- sheath 12 can be proximally retracted to begin the process of “unsheathing” implant 16 .
- implant 16 may begin to immerge from sheath 12 and partially expand within the anatomy.
- coil 174 may begin to return to the unexpanded or shortened configuration. This can be seen in FIG.
- coil 174 is partially shortened and has a less open pitch (e.g., adjacent winding of coil 174 are less spaced from one another than when expanded). Because nose cone 64 may be attached to guidewire tube extension 170 , the shortening of coil 174 may result in the proximal movement of nose cone 64 . Because nose cone 64 may be positioned within the heart (e.g., within the left ventricle), this proximal retraction of nose cone 64 may help to reduce the possibility that nose cone 64 may adversely impact the functioning of the heart. As sheath 12 is further proximally retracted, coil 174 can further shorten (closing the pitch of coil 174 ) and further proximally retract nose cone 64 as shown in FIG. 25 . This may shift nose cone 64 even further away from the ventricles.
- FIGS. 26-27 illustrate another example guidewire tube extension 270 that takes the form of a resilient polymer tube 272 .
- tube 272 may include a resilient polymer (e.g., a resilient polyurethane, a resilient polyester, a resilient polyethylene, a resilient polypropylene, etc.) that is can be stretched and then resiliently returns to it pre-stretched configuration.
- a resilient polymer e.g., a resilient polyurethane, a resilient polyester, a resilient polyethylene, a resilient polypropylene, etc.
- distal forces by outer sheath 12 on nose cone 64 transfer tensile forces onto tube 272 . This may stretch tube 272 into an elongated (and thinned) configuration as shown in FIG. 26 .
- tube 272 As sheath 12 is proximally retracted, the tensile forces on tube 272 are reduced and tube 272 can return to a shortened (and “thickened”) configuration as shown in FIG. 27 . Because tube 272 is attached to nose cone 64 , the shortening of tube 272 results in the proximal shifting of nose cone 64 , which may reduce the possibility that nose cone 64 may adversely impact the functioning of the heart (e.g., the left ventricle) during the intervention.
- FIG. 28 which is also shown schematically, illustrates a portion of an example guidewire tube extension 370 that includes a tube 372 without a nose cone attached thereto.
- guidewire tube extension 370 has a substantially constant outer diameter.
- Guidewire tube extension 370 can be utilized with any of the systems disclosed herein.
- guidewire tube extension 370 may vary. In at least some embodiments, guidewire tube extension 370 may extend to a position adjacent to the distal end of outer sheath 12 when outer sheath 12 is distally advanced sufficiently for sheathing of implant 16 . Alternatively, guidewire tube extension 370 may extend to a position proximal of the distal end of outer sheath 12 (e.g., when outer sheath 12 is in the “sheathing” position). In some of these and in other embodiments, guidewire tube extension 370 may extend to a position proximal of the distal end of outer sheath 12 when outer sheath 12 is refracted. In either case, guidewire tube extension 370 may be generally configured to maintain a guidewire lumen that can be utilized by the clinician, if desired, during the intervention.
- FIGS. 29-30 illustrate another example guidewire tube extension 470 that takes the form of a tubular member 472 having a plurality of slots 476 formed therein.
- tubular member 472 may take the form of a metallic tube (e.g., stainless steel, nickel-titanium alloy, etc.) that has a plurality of slots 476 formed therein.
- slots 476 may be formed in tubular member 472 via a mechanical process such as micromachining
- slots 476 may be formed via a laser cutting process. These are just examples.
- the distribution and/or configuration of slots 476 can vary and may include, to the extent applicable, any of the distributions and/or configurations disclosed in U.S. Pat. Publication No. US 2004/0181174, the entire disclosure of which is herein incorporated by reference.
- Distal forces by outer sheath 12 on nose cone 64 may transfer tensile forces onto tubular member 472 . This may stretch tube tubular member 472 and “open” or expand slots 476 as shown in FIG. 26 . As sheath 12 is proximally retracted, the tensile forces on tubular member 472 may be reduced and tubular member 472 can return to an unexpanded configuration.
- tubular member 472 may be formed from a shape memory and/or super elastic material (e.g., nickel-titanium alloy) that is heat set into a configuration where slots 476 are compressed or “closed” as shown in FIG. 30 .
- a shape memory and/or super elastic material e.g., nickel-titanium alloy
- tubular member 472 may be attached to nose cone 64 , the shortening of tubular member 472 may result in the proximal shifting of nose cone 64 , which may reduce the possibility that nose cone 64 may adversely impact the functioning of the heart (e.g., the left ventricle) during the intervention.
- FIGS. 31-32 illustrate an example outer sheath 512 that may be used with any of the systems disclosed herein.
- sheath 512 includes a deflectable distal region 578 that is configured to shift between a tapered (e.g., deflected radially inward) configuration as shown in FIG. 31 and an open configuration as shown in FIG. 32 .
- the use of outer sheath 512 may allow the use of a guidewire tube extension 572 lacking a nose cone (e.g., similar to what is shown in FIG. 28 ).
- Shifting distal region 578 between the tapered configuration and the open configuration may be achieved by proximally retracting outer sheath 512 . In doing so, outer sheath 512 may deflect radially outward (e.g., when interacting with other components of the system) in order to allow implant 16 (not shown in FIGS. 31-32 ) to be implanted.
- Outer sheath 12 and/or inner catheter 14 may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material.
- suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: NO6625 such as INCONEL® 625, UNS: NO6022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: NO4400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and
- linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does.
- linear elastic and/or non-super-elastic nitinol as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol.
- linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.
- linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.
- the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range.
- DSC differential scanning calorimetry
- DMTA dynamic metal thermal analysis
- the mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature.
- the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region.
- the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.
- the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel.
- a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUMTM (available from Neo-Metrics) and GUM METALTM (available from Toyota).
- a superelastic alloy for example a superelastic nitinol can be used to achieve desired properties.
- portions or all of outer sheath 12 and inner catheter 14 may also be doped with, made of, or otherwise include a radiopaque material.
- Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of system 10 in determining its location.
- Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design of system 10 to achieve the same result.
- outer sheath 12 and inner catheter 14 may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image. Outer sheath 12 and inner catheter 14 , or portions thereof, may also be made from a material that the MRI machine can image.
- Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others.
- cobalt-chromium-molybdenum alloys e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like
- nickel-cobalt-chromium-molybdenum alloys e.g., UNS: R30035 such as MP35-N® and the like
- nitinol and the like, and others.
- a sheath or covering may be disposed over portions or all of outer sheath 12 and inner catheter 14 that may define a generally smooth outer surface for system 10 . In other embodiments, however, such a sheath or covering may be absent from a portion of all of system 10 , such that outer sheath 12 and inner catheter 14 may form an outer surface.
- the sheath may be made from a polymer or other suitable material.
- suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate
- the exterior surface of the system 10 may be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished, etc.
- a coating for example a lubricious, a hydrophilic, a protective, or other type of coating may be applied over portions or all of the sheath, or in embodiments without a sheath over portion of outer sheath 12 and inner catheter 14 , or other portions of system 10 .
- the sheath may comprise a lubricious, hydrophilic, protective, or other type of coating.
- Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves device handling and device exchanges.
- Lubricious coatings improve steerability and improve lesion crossing capability.
- Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof.
- HDPE high-density polyethylene
- PTFE polytetrafluoroethylene
- polyarylene oxides polyvinylpyrolidones
- polyvinylalcohols polyvinylalcohols
- hydroxy alkyl cellulosics algins
- Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility.
- the coating and/or sheath may be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusing several segments end-to-end.
- the layer may have a uniform stiffness or a gradual reduction in stiffness from the proximal end to the distal end thereof. The gradual reduction in stiffness may be continuous as by ILC or may be stepped as by fusing together separate extruded tubular segments.
- the outer layer may be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without deviating from the scope of the present invention.
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Abstract
Description
- This application claims the benefit of U.S. Provisional Application Ser. No. 61/577,899, filed Dec. 20, 2011, the entire disclosure of which is incorporated herein by reference.
- The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to medical devices for delivering a replacement heart valve.
- A wide variety of intracorporeal medical devices have been developed for medical use, for example, intravascular use. Some of these devices include guidewires, catheters, medical device delivery systems (e.g., for stents, grafts, replacement valves, etc.), and the like. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices.
- The invention provides design, material, manufacturing method, and use alternatives for medical devices including medical device delivery systems. An example medical device delivery system may include an outer sheath. An inner catheter may be disposed within the outer sheath. The inner catheter may have a distal end. A tube extension may be coupled to the distal end of the inner catheter and may extend distally therefrom. The tube extension may be configured to shift between a first elongated configuration and a second shortened configuration.
- Another example medical device delivery system may include an outer sheath. An inner catheter may be disposed within the outer sheath. The inner catheter may have a distal portion. A valve implant may be releasably coupled to the distal portion of the inner catheter. A tube extension may be coupled to the distal portion of the inner catheter and may extend distally therefrom. The tube extension may have a distal end that is free of a nose cone.
- Another example medical device delivery system may include an outer sheath having a distal portion. The distal portion may be configured to shift between a tapered configuration where the distal portion is deflected radially inward and an open configuration. An inner catheter may be disposed within the outer sheath. The inner catheter may have a distal end. A valve implant may be releasably coupled to the distal end of the inner catheter.
- The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The Figures, and Detailed Description, which follow, more particularly exemplify these embodiments.
- The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
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FIG. 1 is side view of an example medical device system; -
FIG. 2 is a cross-sectional side view of an example outer sheath; -
FIG. 3 is a transverse cross-sectional view taken through line 3-3 inFIG. 2 ; -
FIG. 3A is a transverse cross-sectional view taken through line 3-3 inFIG. 2 ; -
FIG. 4 is a side view of an example inner catheter; -
FIG. 5 is a cross-sectional view taken through line 5-5 inFIG. 4 ; -
FIG. 6 is a cross-sectional view taken through line 6-6 inFIG. 4 ; -
FIG. 7 is a perspective view of a portion of an example implant associated with the example medical device system; -
FIGS. 8-11 are perspective views that illustrate an example mechanism for locking an implant; -
FIG. 12 is a side view of a portion of an example sheathing aid; -
FIG. 13 is an enlarged plan view illustrating engagement of the example sheathing aid with an example implant; -
FIG. 14 is a side view of an example handle; -
FIG. 15 is a cut away view illustrating some of the interior components of the example handle; -
FIGS. 16-18 illustrate an example of coordinated movement of handle components within the example handle; -
FIGS. 19-20 illustrate the rotation of a collar on the example handle; -
FIGS. 21-22 illustrate some of the components within the example handle during rotation of the collar; -
FIG. 23 is a partial cross-section side view of an example tube extension for use with a medical device delivery system; -
FIG. 24 is a partial cross-section side view of the example tube extension shown inFIG. 23 where the tube extension is in a partially shortened configuration; -
FIG. 25 is a partial cross-section side view of the example tube extension inFIG. 23 where the tube extension is in a further shortened configuration; -
FIG. 26 is a partial cross-section side view of another example tube extension for use with a medical device delivery system; -
FIG. 27 is a partial cross-section side view of the example tube extension shown inFIG. 26 where the tube extension is in a shortened configuration; -
FIG. 28 is a side view of another example tube extension for use with a medical device delivery system; -
FIG. 29 is a partial cross-section side view of another example tube extension for use with a medical device delivery system; -
FIG. 30 is a partial cross-section side view of the example tube extension shown inFIG. 29 where the tube extension is in a shortened configuration; -
FIG. 31 is a side view of a portion of an example sheath for use with a medical device delivery system in a first configuration; and -
FIG. 32 is a side view of a portion of the example sheath shown inFIG. 31 in a second configuration. - While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
- For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
- All numeric values are herein assumed to be modified by the term “about,” whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the term “about” may include numbers that are rounded to the nearest significant figure.
- The recitation of numerical ranges by endpoints includes all numbers within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
- As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
- The following detailed description should be read with reference to the drawings in which similar elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.
- Diseases and/or medical conditions that impact the cardiovascular system are prevalent in the United States and throughout the world. Traditionally, treatment of the cardiovascular system was often conducted by directly accessing the impacted part of the system. For example, treatment of a blockage in one or more of the coronary arteries was traditionally treated using coronary artery bypass surgery. As can be readily appreciated, such therapies are rather invasive to the patient and require significant recovery times and/or treatments. More recently, less invasive therapies have been developed, for example, where a blocked coronary artery could be accessed and treated via a percutaneous catheter (e.g., angioplasty). Such therapies have gained wide acceptance among patients and clinicians.
- Some relatively common medical conditions may include or be the result of inefficiency, ineffectiveness, or complete failure of one or more of the valves within the heart. For example, failure of the aortic valve can have a serious effect on a human and could lead to serious health condition and/or death if not dealt with. Treatment of defective heart valves poses other challenges in that the treatment often requires the repair or outright replacement of the defective valve. Such therapies may be highly invasive to the patient. Disclosed herein are medical devices that may be used for delivering a medical device to a portion of the cardiovascular system in order to diagnose, treat, and/or repair the system. At least some of the medical devices disclosed herein may be used to deliver and implant a replacement heart valve (e.g., a replacement aortic valve). In addition, the devices disclosed herein may deliver the replacement heart valve percutaneously and, thus, may be much less invasive to the patient. The devices disclosed herein may also provide a number of additional desirable features and benefits as described in more detail below.
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FIG. 1 is a side view of an examplemedical device system 10. It should be noted that some features ofsystem 10 are either not shown, or are shown schematically, inFIG. 1 for simplicity. Additional details regarding some of the components ofsystem 10 are provided in other figures in greater detail.System 10 may be used to deliver and/or deploy a variety of medical devices to a number of locations within the anatomy. In at least some embodiments,system 10 is a replacement heart valve delivery system (e.g., a replacement aortic valve delivery system) that can be used for percutaneous delivery of a replacement heart valve. This, however, is not intended to be limiting assystem 10 may also be used for other interventions including mitral, tricuspid, or pulmonary valve replacement, valve repair, valvuloplasty, and the like, or other similar interventions. -
System 10 may generally be described as a catheter system that includes an outer sheath orcatheter 12 and an inner catheter or tube 14 (a portion of which is shown inFIG. 1 in phantom line) extending at least partially throughouter sheath 12. Amedical device implant 16 may be coupled toinner catheter 14 and disposed withinouter sheath 12 during delivery ofimplant 16. Ahandle 18 may be disposed at the proximal end ofouter sheath 12 andinner catheter 14. In general, handle 18 may be configured to manipulate the position ofouter sheath 12 relative toinner catheter 14 as well as aid in the deployment ofimplant 16. - In use,
system 10 may be advanced percutaneously through the vasculature to a position adjacent to an area of interest. For example,system 10 may be advanced through the vasculature to a position adjacent to a defective aortic valve. During delivery,implant 16 may be generally disposed in an elongated and low profile “delivery” configuration withinouter sheath 12. Once positioned,outer sheath 12 may be refracted to exposeimplant 16.Implant 16 may be actuated in order to expand implant into a generally shortened and larger profile “deployed” configuration suitable for implantation within the anatomy. Whenimplant 16 is suitably deployed within the anatomy,system 10 can be removed from the vasculature, leavingimplant 16 in place to function as, for example, a suitable replacement for the native aortic valve. In at least some interventions,implant 16 may be deployed within the native valve (e.g., the native valve is left in place and not excised). Alternatively, the native valve may be removed andimplant 16 may be deployed in its place as a replacement. -
FIGS. 2-13 (as well as other figures) illustrate some of the components ofsystem 10. For example,FIG. 2 is a cross-sectional side view ofouter sheath 12. Here it can be seen thatouter sheath 12 has aproximal portion 20 and adistal portion 22.Distal portion 22 may have a slightly enlarged or flared inner diameter, which may provide additional space for holdingimplant 16 therein. For example, the inner diameter ofouter sheath 12 alongproximal portion 20 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.56388±0.0508 cm (0.222±0.002 inches). The inner diameter ofouter sheath 12 alongdistal portion 22 may be in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.579 to 0.5842 cm (0.228 to 0.230 inches). At the distal end ofdistal portion 22 may be adistal tip 24, which may be flared or otherwise have a funnel-like shape. The funnel-like shape increases the outer diameter (and inner diameter) ofouter sheath 12 atdistal tip 24 and may aid in the sheathing and/or resheathing ofimplant 16 intoouter sheath 12. Other than atdistal tip 24,outer sheath 12 may have a generally constant outer diameter. For example,outer sheath 12 may have an outer diameter in the range of about 0.254 to 1.27 cm (0.10 to 0.50 inches), or about 0.508 to 1.016 cm (0.20 to 0.40 inches), or about 0.508 to 0.762 cm (0.20 to 0.30 inches), or about 0.6858 cm (0.270 inches). These are just examples. Other embodiments are contemplated that have differing dimensions (including those appropriate for differently sized patients including children) and/or arrangements for the outer diameter and/or inner diameter ofouter sheath 12. These contemplated embodiments include outer sheaths with flared or otherwise variable outer diameters (including, but not limited to, a plurality of tapered sections), embodiments with constant inner diameters, combinations thereof, and the like.Outer sheath 12 may also have a length that is appropriate for reaching the intended area of interest within the anatomy. For example,outer sheath 12 may have a length in the range of about 30 to 200 cm, or about 60 to 150 cm, or about 100 to 120 cm, or about 108±0.20 cm.Outer sheath 12 may also be curved. For example, a distal section ofouter sheath 12 may be curved. In one example, the radius of the curve (measured from the center of outer sheath 12) may be in the range of about 2 to 6 cm (20 to 60 mm), or about 3 to 4 cm (30 to 40 mm), or about 3.675 cm (36.75 mm). Again, these dimensions are examples and are not intended to be limiting. -
Outer sheath 12 may be formed from a singular monolithic tube or unitary member. Alternatively,outer sheath 12 may include a plurality of layers or portions. One or more of these layers may include a reinforcing structure such as a braid, coil, mesh, combinations thereof, or the like.FIG. 3 illustrates one example of a multilayer structure forouter sheath 12. For example,outer sheath 12 may include an inner liner orlayer 26. An intermediate ortier layer 28 may be disposed oninner liner 26. Areinforcement 30 may be disposed onintermediate layer 28. A topcoat orouter layer 32 may be disposed onreinforcement 30. Finally, an outer coating 34 (e.g., a lubricious coating, a hydrophilic coating, a hydrophobic coating, etc.) may be disposed along portions or all oftopcoat 32. These are just examples. Several alternative structural configurations are contemplated forouter sheath 12 including embodiments including two or more layers that may be different from those shown inFIG. 3 , embodiments without a reinforcement, and the like, or other suitable configurations. - The dimensions and materials utilized for the various layers of
outer sheath 12 may also vary. For example,inner liner 26 may include a polymeric material, preferably having a low coefficient of friction, such as fluorinated ethylene propylene (FEP) and may have a thickness in the range of about 0.00254 to 0.0127 cm (0.001 to 0.005 inches) or about 0.00762±0.00254 (0.003±0.001 inches),intermediate layer 28 may include a polymer material such as polyether block amide (e.g., PEBAX 6333) and may have a thickness in the range of about 0.00254 to 0.0127 cm (0.001 to 0.005 inches) or about 0.00508±0.00254 (0.002±0.001 inches),outer coating 34 may include a polymer material such as polyether block amide (e.g., PEBAX 7233) and may have a thickness in the range of about 0.00254 to 0.0254 cm (0.001 to 0.01 inches). In some embodiments,outer coating 34 may vary in thickness. For example, alongproximal portion 20outer coating 34 may have greater thickness, such as about 0.0127 to about 0.0508 cm or about 0.02159 cm (0.005 to 0.02 inches or about 0.0085 inches), than alongdistal portion 22 and/ordistal tip 24, which may be about 0.0127 to about 0.0508 cm or about 0.01651 cm (e.g., about 0.005 to 0.02 inches or about 0.0065 inches). These are just examples as other suitable materials may be used. - The form of
distal tip 24 may also vary. For example, in at least some embodiments, inner liner 26 (i.e., a 2.5 mm section thereof) may be extended up and around the distal end of outer sheath 12 (e.g., aroundreinforcement 30 and topcoat 32). A ring member (not shown) made from a suitable material such as a 55D polyether block amide (e.g., 55D PEBAX) may be disposed overinner liner 26 and heat bonded to formdistal tip 24. This may form the funnel-like shape ofdistal tip 24. -
Reinforcement 30 may also vary in form. In at least some embodiments,reinforcement 30 may take the form of a braid, coil, mesh, or the like. For example, in some embodiments,reinforcement 30 may include a metallic braid (e.g., stainless steel). In some of these embodiments,reinforcement 30 may also include additional structures such as one or more longitudinally-extending strands. For example,reinforcement 30 may include a pair of longitudinally-extending aramid and/or para aramid strands 31 (for example, KEVLAR®) disposed on opposite sides of the braid, as seen inFIG. 3A . Thestrands 31 may or may not be woven into portions or all of the braid. -
FIG. 4 is a side view of theinner catheter 14. A distal end region ofinner catheter 14 may include a step inouter diameter 40 that defines a decreasedouter diameter section 42. For example, decreasedouter diameter section 42 may have an outer diameter in the range of about 0.127 to 0.635 cm (0.05 to 0.25 inches), or about 0.254 to 0.508 cm (0.10 to 0.20 inches), or about 0.38608±0.00762 (0.152±0.003 inches) as opposed to the remainder ofinner catheter 14 where the outer diameter may be in the range of about 0.127 to 0.762 cm (0.05 to 0.30 inches), or about 0.254 to 0.635 cm (0.10 to 0.25 inches), or about 0.508±0.0254 cm (0.20±0.01 inches). Decreasedouter diameter section 42 may define a region where other components ofsystem 10 may be attached. Some additional details regarding these components can be found herein. In general,inner catheter 14 may take the form of an extruded polymer tube. - Other forms are also contemplated including other polymer tubes, metallic tubes, reinforced tubes, or the like including other suitable materials such as those disclosed herein. In some embodiments,
inner catheter 14 is a singular monolithic or unitary member. In other embodiments,inner catheter 14 may include a plurality of portions or segments that are coupled together. The total length of inner catheter may be in the range of about 60 to 150 cm, or about 80 to 120 cm, or about 100 to 115 cm, or about 112±0.02 cm. Just likeouter sheath 12,inner catheter 14 may also be curved, for example adjacent to the distal end thereof. In some embodiments,inner catheter 14 may have one or more sections with a differing hardness/stiffness (e.g., differing shore durometer). For example, inner catheter may have aproximal region 44 a and anintermediate region 44 b.Proximal region 44 a may include a generally stiff polymeric material such as a 72D polyether block amide (e.g., 72D PEBAX) and may have a length in the range of about 60 to 150 cm, or about 80 to 120 cm, or about 100 to 115 cm, or about 109.5±0.02 cm.Intermediate region 44 b may include a 40D polyether block amide (e.g., 40D PEBAX) and may have a length in the range of about 5 to 25 mm, or about 10 to 20 mm, or about 15±0.01 mm.Section 42 may also differ fromregions 44 a/44 b and, in some embodiments, may include a 72D polyether block amide (e.g., 72D PEBAX) and may have a length in the range of about 0.5 to 2 cm (5 to 20 mm), or about 0.8 to 1.5 cm (8 to 15 mm), or about 1±0.001 cm (10±0.01 mm). These are just examples. -
Inner catheter 14 may include one or more lumens. For example,FIG. 5 (which is a cross sectional view ofinner catheter 14 adjacent to proximal end portion 36) illustrates thatinner catheter 14 may include afirst lumen 46, asecond lumen 48, athird lumen 50, and afourth lumen 52. In general,lumens 46/48/50/52 extend along the entire length ofinner catheter 14. Other embodiments are contemplated, however, where one or more oflumens 46/48/50/52 extend along only a portion of the length ofinner catheter 14. For example,fourth lumen 52 may stop just short of the distal end ofinner catheter 14 and/or be filled in at its distal end to effectively endfourth lumen 52 proximal of the distal end ofinner catheter 14, as illustrated inFIG. 6 by the absence offourth lumen 52 adjacent to the distal end ofinner catheter 14. - Disposed within
first lumen 46 may be push-pull rods 84 (not shown inFIG. 5 , seen in other figures includingFIG. 7 ), which are used to expand and/orelongate implant 16 as explained in more detail herein. In at least some embodiments,first lumen 46 may be lined with a low friction liner 54 (e.g., a FEP liner). Disposed withinsecond lumen 48 may be a pin release mandrel 92 (not shown inFIG. 5 , seen in other figures includingFIG. 7 ), which is also explained in more detail herein. In at least some embodiments,second lumen 48 may be lined with ahypotube liner 56.Third lumen 50 may be a guidewire lumen and this lumen may also be lined with ahypotube liner 58. -
Fourth lumen 52 may be used to house anon-stretch wire 60. The form ofnon-stretch wire 60 may vary. In some embodiments,non-stretch wire 60 may take the form of a stainless steel braid. Thenon-stretch wire 60 may optionally include a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides of the braid. In general, rather than being “disposed within”fourth lumen 52,non-stretch wire 60 may be embedded withinfourth lumen 52. In addition,non-stretch wire 60 may extend to a position adjacent todistal end portion 38 but not fully to the distal end ofinner catheter 14 as illustrated inFIG. 6 by the absence offourth lumen 52 adjacent to the distal end ofinner catheter 14. For example, a short distal segment offourth lumen 52 may be filled in with polymer material adjacent to the distal end ofinner catheter 14. -
Inner catheter 14 may also include aguidewire tube extension 62 that extends distally fromdistal end portion 38. Anose cone 64 is attached toguidewire tube extension 62.Nose cone 64 generally is designed to have an atraumatic shape.Nose cone 64 may also include a ridge orledge 66 that is configured to abut thedistal tip 24 ofouter sheath 12 during delivery ofimplant 16. -
FIG. 7 illustrates some of the additional components ofsystem 10 andimplant 16. For example, here it can be seen thatimplant 16 includes a plurality of valve leaflets 68 (e.g., bovine pericardial) which are secured to acylindrical braid 70 at a post orcommissure post 72, for example at the commissure portions of theleaflets 68. In this example,implant 16 includes threeleaflets 68 secured to braid 70 with threeposts 72.Leaflets 68 may also be secured to the base or “distal end” ofbraid 70. Theposts 72, in turn, may be secured to braid 70 (e.g., along the interior of braid 70) with sutures or other suitable mechanisms. Positioned adjacent to (e.g., longitudinally spaced from and aligned with) posts 72 are a plurality ofbuckles 76, which may also be sutured to braid 70 (e.g., along the interior of braid 70). In this example, onebuckle 76 is attached to braid 70 adjacent to each of the threeposts 72. Accordingly,braid 70 has a total of threebuckles 76 and threeposts 72 attached thereto. Other embodiments are contemplated where fewer ormore buckles 76 andposts 72 may be utilized. A seal 74 (shown in cross-section) may be disposed aboutbraid 70 and, as the name suggests, may help to sealimplant 16 within a target implant site or area of interest, thereby preventing blood leakage around the device (i.e., paravalvular regurgitation, etc.). - Attachment between
implant 16 and inner catheter 14 (and/or outer sheath 12) may be effected through the use of a threefinger coupler 78.Coupler 78 may generally include a cylindrical base (not shown) that is attached to inner catheter 14 (e.g., disposed about and attached to reduced outer diameter section 42). Projecting distally from the base are three fingers that are each configured to engage withimplant 16 atposts 72 and buckles 76. Acollar 80 may further assist in holding together these structures. Aguide 82 may be disposed over each of the fingers and may serve to keep the fingers ofcoupler 78 associated with push-pull rods 84 extending adjacent tocoupler 78. Finally, apin release assembly 86 may be a linking structure that keepsposts 72, buckles 76, and push-pull rods 84 associated with one another.Pin release assembly 86 includes a plurality ofindividual pins 88 that may be joined together via acoiled connection 90 and held to apin release mandrel 92 with aferrule 94. - During delivery,
implant 16 is secured at the distal end ofinner catheter 14 by virtue of the association of the fingers ofcoupler 78 being coupled with a projecting proximal end of buckles 76 (and being held in place withcollar 80 disposed over the connection) and by virtue ofpins 88 securing together push-pull rods 84 and posts 72. Whenimplant 16 is advanced within the anatomy to the desired location,outer sheath 12 may be withdrawn (e.g., moved proximally relative to inner catheter 14) to exposeimplant 16. Then, push-pull rods 84 can be used to expand and “lock”implant 16 in the expanded or deployed configuration by proximally retracting push-pull rods 84 to pullposts 72 into engagement with buckles. Finally, pins 88 can be removed, thereby uncoupling push-pull rods 84 fromposts 72, which allowsimplant 16 to be released fromsystem 10 and deployed in the anatomy. -
FIGS. 8-11 illustrate the locking system utilized withsystem 10. For simplicity purposes, only one of the three fingers of thecoupler 78, only one of the three push-pull rods 84, and only one of theposts 72 of theexample system 10 are shown (andimplant 16 is not shown). As seen inFIG. 8 , push-pull rod 84 extends throughguide 82 adjacent to the fingers ofcoupler 78, throughcollar 80, throughbuckle 76, and into a hollow t-shapedbar portion 96 ofpost 72. The distal end of push-pull rod 84 may include an opening or aperture (not shown) that can be aligned with anopening 98 of t-shapedbar portion 96. When so aligned, pin 88 can be looped throughopening 98 and the opening of push-pull rod 84. This secures push-pull rod 84 to post 72 and forms a configuration of these structures that can be utilized during delivery ofimplant 16. As can be appreciated, the proximal end ofpost 72 and the distal end ofbuckle 76 are longitudinally separated and, accordingly,implant 16 is in an elongated and generally low-profile configuration suitable for delivery. - When
implant 16 reaches the intended target site within the anatomy, a clinician can proximally retract push-pull rod 84, thereby moving the proximal ends ofposts 72 toward the distal ends ofbuckles 76 in order to expandimplant 16. Ultimately, push-pull rod 84 can be retracted sufficiently far enough to lockpost 72 withbuckle 76 so as to lock implant in an expanded configuration suitable for implantation within the anatomy.FIG. 9 illustrates push-pull rod 84 proximally retracted. In doing so, post 72 is brought into contact withbuckle 76. More particularly, a raised, generally transversely-orientedridge 100 on t-shapedbar portion 96 may be pulled proximally pastbuckle 76 so thatpost 72 is secured and held in place bybuckle 76. At this point, it is possible to urge push-pull rods 84 distally to “unlock”implant 16, thereby allowing for repositioning and/or retraction. Alternatively, if a clinician is satisfied with the positioning and/or locking of implant 16 (e.g., after visualization ofimplant 16 via a suitable imaging technique), pins 88 may be pulled (e.g., removed fromopenings 98 and the openings in push-pull rods 84) to uncouple push-pull rods 84 fromposts 72 as shown inFIG. 10 . Further retraction of push-pull rods 84 causes a longitudinally-orientedridge 102 on push-pull rods 84 to engagecollar 80 and causescollar 80 to slide proximally along the fingers ofcoupler 78. In doing so, a forkedend 104 of the fingers, which has agroove 106 formed therein, is exposed and can be uncoupled from arail 108, which has aprojection 110 formed thereon that is configured to mate withgroove 106, as shown inFIG. 11 . Thereafter,system 10 can be removed from the anatomy, leaving behind the expanded and deployedimplant 16. -
FIGS. 12-13 illustrate another component that may be included withsystem 10. For example,FIG. 12 is a side view of a portion of asheathing aid 112. Here it can be seen thatsheathing aid 112 includes abase 114 and a group of petals including a set of threelonger petals 116 and a pair ofshorter petals 118. In use, a group ofpetals 116/118 may be positioned between each of the fingers ofcoupler 78. Because thecoupler 78 may have a total of three fingers,sheathing aid 112 may have a total of fifteen petals (e.g., three groups that each include three “long”petals 116 and two “short”petals 118, with each group being positioned between adjacent pairs of fingers of coupler 78).Base 114 may be secured toinner catheter 14 adjacent to coupler 78 (e.g., underneathcoupler 78 and betweencoupler 78 and inner catheter 14). -
Sheathing aid 112, as the name suggests, may be used to aid in the sheathing ofimplant 16 intoouter sheath 12. In addition,sheathing aid 112 may aid in the initial sheathing of implant 16 (e.g., removingimplant 16 from a packaging container such as a bottle and pullingimplant 16 into outer sheath 12) and inre-sheathing implant 16 during repositioning and/or retraction ofimplant 16 within the area of interest. Sheathing may be accomplished via the arrangement and positioning of thevarious petals 116/118. For example,FIG. 13 illustrates thelonger petals 116 woven in and out ofbraid 70, and theshorter petals 118 disposed along the exterior ofbraid 70 acting as a funnel for sheathing. -
FIG. 14 is a side view ofhandle 18. Here it can be seen that handle 18 includes ahandle housing 120. Arotatable control knob 122 may be disposed about handle housing 120 (e.g., at a proximal end of handle housing 120) and may be used to move one or more of the components of system 10 (e.g.,outer sheath 12, push-pull rods 84, etc.). Arotatable collar 156 may be disposed about thehandle housing 120.Control knob 122 may be disposed about a proximal portion ofcollar 156. Aslidable door 124 may also be disposed abouthandle housing 120.Door 124 may translate distally to expose a distal portion of rotatable collar 156 (not shown inFIG. 14 , can be seen in other figures includingFIGS. 19-20 ) positioned generally underdoor 124.Collar 156 may be rotated to move one or more components of system 10 (e.g., push-pull rods 84,pin release mandrel 92, etc.).Handle 18 may also include one ormore apertures 129 a/129 b and/orflush ports 126/128 that can be used to flushsystem 10. In some embodiments, distalflush port 126 and proximalflush port 128 may be accessible from the exterior of thehandle housing 120 throughdistal aperture 129 a andproximal aperture 129 b, respectively. -
FIG. 15 is a side view ofhandle 18 with a portion ofhandle housing 120 removed, exposing at least some of the interior components. Here it can be seen thatouter sheath 12 may be attached to asheath adapter 130.Sheath adapter 130 is attached to asheath carriage 132, which may be threaded onto alead screw 134. Distalflush port 126 may be disposed onsheath adapter 130. In general, distalflush port 126 provides access to the interior or lumen of outer sheath 12 (e.g., access to space betweeninner catheter 14 and outer sheath 12) so that a clinician can flush fluid through the lumen ofouter sheath 12 to remove any unwanted materials (e.g., air, fluid, contaminants, etc.) therein prior to use ofsystem 10. In at least some embodiments, distalflush port 126 has a luer type connector (e.g., a one-way luer connector) that allows a device such as a syringe with a corresponding connector to be attached thereto for flushing. - Extending through and proximally from
sheath adapter 130 isinner catheter 14. A proximal end ofinner catheter 14 is attached (e.g., fixedly attached) to an interior body ordiverter 136.Diverter 136 is attached to asupport body 140. In general,diverter 136 and/orsupport body 140 may have one or more passageways or lumens formed therein. In some embodiments, push-pull rods 84 and/orpin release mandrel 92 may extend through respective passageways. Alternatively, the proximal ends of push-pull rods 84 and/orpin release mandrel 92 may each be attached to a shaft or hypotube (e.g., solid in cross-section, tubular, etc.), and each of the shafts may extend through the one or more passageways. For example, a first shaft or hypotube 142 and a second shaft orhypotube 144 may extend through the passageways indiverter 136, and in some embodiments, the first shaft orhypotube 142 extends through a first passageway and the second shaft orhypotube 144 extends through a second passageway that is separate or distinct from the first passageway. In at least some embodiments,first shaft 142 is attached to pinrelease mandrel 92. In at least some embodiments,second shaft 144 is attached to push-pull rods 84. It should be noted that at in least some embodiments ofsystem 10, three push-pull rods 84 are utilized. In these embodiments, the three push-pull rods 84 come together (e.g., brought into contact with one another or otherwise brought into relatively close proximity with one another) adjacent to the distal end ofinner catheter 14 and enterfirst lumen 46. At one or more positions along their length, push-pull rods 84 may be attached to one another. For example, in some embodiments, push-pull rods 84 may be welded together about 10.16 cm (about 4.00 inches) from their distal ends. In some embodiments, push-pull rods 84 may be welded together proximate their proximal ends in addition to or instead of the distal weld. Proximally thereafter, push-pull rods 84 may extend tosecond shaft 144. - A hypotube (e.g.,
hypotube liner 58 disposed along guidewire lumen 52) may extend throughdiverter 136 within a passageway therein and then be “diverted” around a portion ofdiverter 136 andsupport body 140, and ultimately be extended to a position at the proximal end ofhandle 18 so as to provide a user access toguidewire lumen 52. Proximalflush port 128 may be disposed onsupport body 140 that can be used to flush the lumens ofinner catheter 14 and, for example, may function similarly to distalflush port 126. - At their respective proximal ends,
first shaft 142 may be secured to aslider 146 andsecond shaft 144 may be secured to aforce limiter body 150. The connections between the various components may include a number of different types of connections including mechanical bonding (e.g., pinning, threading, interference fit, etc.), adhesive bonding, thermal bonding, etc.Slider 146 may be slidable relative to forcelimiter body 150. In some embodiments,slider 146 may be selectively locked to forcelimiter body 150, thereby preventing relative movement between theslider 146 and theforce limiter body 150.Force limiter body 150 may be secured to a push-pull rod carriage 152, which may be threaded ontolead screw 134. Thus, movement oflead screw 134 can cause movement of push-pull rod carriage 152 andforce limiter body 150 and thus, push-pull rods 84 (via second shaft 144). Some additional details regarding this motion can be found herein. - In general,
force limiter body 150 forms or defines a stop point that provides tactile feedback (e.g., resistance to further rotation of control knob 122) to the user indicating that push-pull rods 84 have been retracted proximally a sufficient distance to lockposts 72 withbuckles 76. To verify proper locking, a clinician may use an appropriate visualization technique to visualize proper locking (e.g., the relative positioning of theposts 72 and the buckles 76). Achock 148 may be positioned adjacent toslider 146 to selectively lockslider 146 to forcelimiter body 150. In order to allowpin release mandrel 92 to be proximally retracted to pullpins 88, chock 148 can be rotated or otherwise moved to a secondary position or configuration. When in this configuration, chock 148 no longer forms a barrier to further movement of, for example,slider 146 andpin release mandrel 92. Accordingly, withchock 148 no longer acting as an impediment,slider 146 andpin release mandrel 92 can be proximally retracted to facilitate deployment ofimplant 16 by allowingpins 88 to be pulled. -
Handle 18 also includes arotatable ring 155 with internal teeth that are configured to engage with teeth on agear 157 coupled to leadscrew 134.Ring 155 is coupled to controlknob 122 so that rotation ofcontrol knob 122 results in analogous motion ofring 155 and thuslead screw 134. -
Handle 18 is generally configured for coordinated movement of multiple structures ofsystem 10. For example, handle 18 is configured to allow a user to move outer sheath 12 (e.g., relative to inner catheter 14), move push-pull rods 84, and movepin release mandrel 92. Moreover, handle 18 is configured so that the appropriate structure can be moved at the appropriate time during the intervention so thatimplant 16 can be delivered in an efficient manner. Some examples of how the coordinated movement ofsystem 10 may occur withinhandle 18 may be similar to those disclosed in U.S. Patent Application Pub. No. US 2010/0280495, the entire disclosure of which is herein incorporated by reference. - To help facilitate the coordinated movement, handle 18 may include a lost
motion barrel 158.Lost motion barrel 158 is configured to engagecarriages 132/152 and/or screws associated withcarriages 132/152 at different times during the intervention to stop motion (e.g., create “lost motion” of the appropriate carriage).FIGS. 16-19 illustrate some of the coordinated motion achieved byhandle 18. It should be noted that some elements ofsystem 10 are not shown inFIGS. 16-20 for clarity. For example,FIG. 16 illustrates a first position or state forhandle 18 whereouter sheath 12 is extended distally relative to inner catheter 14 (and handle 18) so as to fully sheath (e.g., contain)implant 16. While in this position,sheath carriage 132 is positioned adjacent to the distal end ofhandle 18. In addition, arod screw 152 a associated with push-pull rod carriage 152 is extended distally from push-pull rod carriage 152 and positioned within lostmotion barrel 158. Upon rotation of control knob 122 (e.g., in the clockwise direction),lead screw 134 begins to rotate. Rotation oflead screw 134 causessheath carriage 132 to move alonglead screw 134 in the proximal direction, resulting in proximal movement of outer sheath 12 (e.g., “unsheathing” implant 16). This initial rotation oflead screw 134 also causesrod screw 152 a to rotate. This may be because, for example, a knob or projection (not shown) onrod screw 152 a may be engaged with a helical thread disposed along the interior of lostmotion barrel 158. However, becauserod screw 152 a is spaced from push-pull rod carriage 152, it does not exert a force onto push-pull rod carriage 152. Thus, initial motion ofcontrol knob 122 does not result in movement of push-pull rod carriage 152 and, instead, only results in translation ofsheath carriage 132 and rotation (and translation) ofrod screw 152 a. - Eventually,
rod screw 152 a (e.g., the knob formed therein) reaches an essentially linear thread or pathway formed at the end of lostmotion barrel 158. The linear thread allowsrod screw 152 a to translate alonglead screw 134 to a position whererod screw 152 a contacts (e.g., is threaded within and abuts) push-pull rod carriage 152. In doing so,rod screw 152 a can contact and move proximally push-pull carriage 152. Accordingly, further rotation oflead screw 134 not only causessheath carriage 132 to move proximally but also causes push-pull rod carriage 152 to move proximally as shown inFIG. 17 . - When
sheath carriage 132 reaches lostmotion barrel 158, asheath carriage screw 132 a ofsheath carriage 132 enters lostmotion barrel 158 as shown inFIG. 18 . This may occur in a manner similar to how rod screw 152 a threads and unthreads with the helical thread formed along lostmotion barrel 158. For example, whilesheath carriage 132 is translating,sheath carriage screw 132 a may follow an essentially linear thread or pathway formed along or adjacent to lostmotion barrel 158. Upon reaching lostmotion barrel 158,sheath carriage screw 132 a (e.g., a knob or projection formed thereon) may shift into engagement with the helical thread within lostmotion barrel 158 and rotate. This rotation “unthreads”sheath carriage screw 132 a fromsheath carriage 132. Accordingly, additional rotation oflead screw 134 results in continued proximal movement of push-pull rod carriage 152 while motion ofsheath carriage 132 ceases. - In at least some embodiments,
lead screw 134 has a plurality of portions, for example afirst portion 134 a and asecond portion 134 b, with a differing pitch to its thread. This may allowcarriages 132/152 to travel at different rates alonglead screw 134. For example, the pitch oflead screw 134 along whichsheath carriage 132 translates may be generally more spaced or slanted than at positions adjacent to push-pull rod carriage 152. Accordingly, the coordinated movement ofcarriages 132/152 also may be configured so thatsheath carriage 132 translates alonglead screw 134 at a greater rate than push-pull rod carriage 152. Other configurations are contemplated where the above-mentioned configuration is reversed as well as further configurations where the pitch oflead screw 134 is essentially constant or includes a number of different pitch regions. - Sufficient proximal retraction of push-
pull rod carriage 152, for example as shown inFIG. 18 , may result in push-pull rods 84 being sufficiently retracted so thatposts 72 can engage and lock withbuckles 76. When the clinician is satisfied that locking is complete (e.g., after verification via an appropriate visualization technique), the clinician may proximally retractpin release mandrel 92 in order to pullpins 88 fromopenings 98 and openings in push-pull rods 84 to releaseimplant 16. - To initiate release of
pins 88,door 124 may be slid distally along a collar 156 (which is positioned on handle 18) as shown inFIG. 19 . Whendoor 124 is sufficiently advanced,door 124 andcollar 156, together, can be rotated as shown inFIG. 20 . Push-pull rod carriage 152 may also include a radially-extendingproximal flag member 164. In general,flag member 164 may be designed as a feature that can preventcollar 156 from being rotated earlier than desired (and, thus, preventpins 88 from being pulled earlier than desired). For example,flag member 164 may be positioned within and follow a groove (not shown) along the interior ofcollar 156. While positioned within the groove,flag member 164 essentially forms a physical barrier that preventscollar 156 from rotating relative to handlehousing 120. When push-pull rod carriage 152 is translated proximally to the back of handle housing 120 (e.g., when push-pull rods 84 are proximally retracted so as to lockposts 72 with buckles 76),flag member 164 exits the groove incollar 156. Accordingly,flag member 164 no longer impedes rotation ofcollar 156 and, as such,collar 156 can now be rotated to pull pins 88. -
Collar 156, viaring 154, is associated with agear 160 engaged with asecondary screw 162. Notches at a proximal end ofcollar 156 engage protrusions onring 154 such that rotation ofcollar 156 causes corresponding rotation ofring 154 and thussecondary screw 162. The initial rotation ofcollar 156 is sufficient to rotate chock 148 (e.g., via a mechanical interaction betweencollar 156 and chock 148 that causes chock 148 to shift) from a first configuration where slider 146 (and, thus, pin release mandrel 92) is selectively locked to forcelimiter body 150, to a secondary configuration, which permitsslider 146 to translate alongsecondary screw 162 assecondary screw 162 rotates, to proximally retract and pull pins 88 (e.g., via pin release mandrel 92). As seen inFIG. 21 ,chock 148 in the first configuration engages aridge 168 along a top portion offorce limiter body 150 which forms a physical barrier that prevents proximal translation ofslider 146 relative to forcelimiter body 150. Whencollar 156 is rotated to shiftchock 148 into the secondary configuration,slider 146 can translate proximally within agroove 166 disposed in the top portion of force limiter body 150 (e.g., as seen inFIG. 22 ), ascollar 156 is rotated about thehandle housing 120 to pull thepins 88 from theopenings 98 and the openings in the distal ends of the push-pull rods 84. Once pins 88 have been removed, push-pull rods 84 may be withdrawn fromimplant 16, thereby deploying the implant at the target site (area of interest). - Following deployment of the
implant 16, thecontrol knob 122 may be rotated to move thesheath carriage 132 distally within thehandle housing 120, thereby movingouter sheath 12 distally relative toinner catheter 14 and three-finger coupler 78 so as to cover or re-sheath the elements ofsystem 10 disposed at the distal end.System 10 may then be removed from the patient's anatomy. - In embodiments where
implant 16 is a replacement aortic valve, implantation ofimplant 16 may include the positioning of at least a portion ofsystem 10 across the native aortic valve and within the heart. For example, asimplant 16 is positioned and implanted across the native valve,guidewire tube extension 62 and/ornose cone 64 may be disposed within the heart. It may be possible that during an intervention,nose cone 64, for example, could lie within the left ventricle and could interfere with or otherwise impact the functioning of the left ventricle (and/or other portions of the heart). - In order to reduce the possibility that portions of
system 10 may impact the function of the heart during an intervention, a number of alternative guidewire tube extensions are contemplated. For example,FIGS. 23-25 illustrates an exampleguidewire tube extension 170 that is configured to shift between an elongated configuration and a shortened configuration. It should be noted that for simplicity purposes, only a portions of the delivery system are shown inFIGS. 23-25 (as well as other figures) some of the structures illustrated in these figures are shown schematically (e.g.,implant 16 is shown schematically). However, it can be appreciated that the features shown in these figures can be applied to any of the delivery systems disclosed herein and/or components of delivery systems disclosed herein. -
Guidewire tube extension 170 may include atubular body 172 that includes or otherwise takes the form of anexpandable coil 174. In some embodiments,tubular body 172 may be sleeve or tube that coverscoil 174. In other embodiments,tubular body 172 may be defined bycoil 174. In addition, guidewire tube extension 170 (as well as other guidewire tube extensions disclosed herein) may include other features ofguidewire tube extension 62 such as a pair of longitudinally-extending aramid and/or para aramid strands (for example, KEVLAR®) disposed on opposite sides oftubular body 172.Coil 174 may be biased to be in an unexpanded configuration and also be configured to expand and/or elongate in response to tensile forces. For example, assheath 12 is advanced distally so as begin to “sheath”implant 16,sheath 12 may contactnose cone 64. Further advancement ofsheath 12 may exert a force in the distal direction, which in turn may exert a tensile force oncoil 174. This may elongatecoil 174 and open the pitch of coil 174 (e.g., where adjacent windings ofcoil 174 are spaced from one another). - When
implant 16 is fully sheathed (e.g., as shown inFIG. 23 ), the delivery system (including guidewire tube extension 170) can be navigated through the anatomy to a position adjacent to a target location. When properly positioned,sheath 12 can be proximally retracted to begin the process of “unsheathing”implant 16. As this occurs,implant 16 may begin to immerge fromsheath 12 and partially expand within the anatomy. However, because the tensile forces oncoil 174 are reduced by the proximal retraction ofsheath 12,coil 174 may begin to return to the unexpanded or shortened configuration. This can be seen inFIG. 24 , wherecoil 174 is partially shortened and has a less open pitch (e.g., adjacent winding ofcoil 174 are less spaced from one another than when expanded). Becausenose cone 64 may be attached toguidewire tube extension 170, the shortening ofcoil 174 may result in the proximal movement ofnose cone 64. Becausenose cone 64 may be positioned within the heart (e.g., within the left ventricle), this proximal retraction ofnose cone 64 may help to reduce the possibility thatnose cone 64 may adversely impact the functioning of the heart. Assheath 12 is further proximally retracted,coil 174 can further shorten (closing the pitch of coil 174) and further proximally retractnose cone 64 as shown inFIG. 25 . This may shiftnose cone 64 even further away from the ventricles. -
FIGS. 26-27 illustrate another exampleguidewire tube extension 270 that takes the form of aresilient polymer tube 272. In at least some embodiments,tube 272 may include a resilient polymer (e.g., a resilient polyurethane, a resilient polyester, a resilient polyethylene, a resilient polypropylene, etc.) that is can be stretched and then resiliently returns to it pre-stretched configuration. In this example, distal forces byouter sheath 12 onnose cone 64 transfer tensile forces ontotube 272. This may stretchtube 272 into an elongated (and thinned) configuration as shown inFIG. 26 . Assheath 12 is proximally retracted, the tensile forces ontube 272 are reduced andtube 272 can return to a shortened (and “thickened”) configuration as shown inFIG. 27 . Becausetube 272 is attached tonose cone 64, the shortening oftube 272 results in the proximal shifting ofnose cone 64, which may reduce the possibility thatnose cone 64 may adversely impact the functioning of the heart (e.g., the left ventricle) during the intervention. - Another embodiment that is contemplated for reducing the possibility that
nose cone 64 could impact the functioning of the heart is simply to omit the nose cone altogether.FIG. 28 , which is also shown schematically, illustrates a portion of an exampleguidewire tube extension 370 that includes atube 372 without a nose cone attached thereto. In at least some embodiments,guidewire tube extension 370 has a substantially constant outer diameter.Guidewire tube extension 370 can be utilized with any of the systems disclosed herein. - The length and/or positioning of the distal end of
guidewire tube extension 370 may vary. In at least some embodiments,guidewire tube extension 370 may extend to a position adjacent to the distal end ofouter sheath 12 whenouter sheath 12 is distally advanced sufficiently for sheathing ofimplant 16. Alternatively,guidewire tube extension 370 may extend to a position proximal of the distal end of outer sheath 12 (e.g., whenouter sheath 12 is in the “sheathing” position). In some of these and in other embodiments,guidewire tube extension 370 may extend to a position proximal of the distal end ofouter sheath 12 whenouter sheath 12 is refracted. In either case,guidewire tube extension 370 may be generally configured to maintain a guidewire lumen that can be utilized by the clinician, if desired, during the intervention. -
FIGS. 29-30 illustrate another exampleguidewire tube extension 470 that takes the form of atubular member 472 having a plurality ofslots 476 formed therein. For example,tubular member 472 may take the form of a metallic tube (e.g., stainless steel, nickel-titanium alloy, etc.) that has a plurality ofslots 476 formed therein. In some embodiments,slots 476 may be formed intubular member 472 via a mechanical process such as micromachining Alternatively,slots 476 may be formed via a laser cutting process. These are just examples. The distribution and/or configuration ofslots 476 can vary and may include, to the extent applicable, any of the distributions and/or configurations disclosed in U.S. Pat. Publication No. US 2004/0181174, the entire disclosure of which is herein incorporated by reference. - Distal forces by
outer sheath 12 on nose cone 64 (not shown inFIGS. 29-30 , but may be attached to a distal end of tubular member 472) may transfer tensile forces ontotubular member 472. This may stretchtube tubular member 472 and “open” or expandslots 476 as shown inFIG. 26 . Assheath 12 is proximally retracted, the tensile forces ontubular member 472 may be reduced andtubular member 472 can return to an unexpanded configuration. In at least some embodiments,tubular member 472 may be formed from a shape memory and/or super elastic material (e.g., nickel-titanium alloy) that is heat set into a configuration whereslots 476 are compressed or “closed” as shown inFIG. 30 . Thus, the reduction in the tensile forces ontubular member 472 may allowtubular member 472 to return to the shortened or compressed configuration (e.g., as shown inFIG. 30 ). Becausetubular member 472 may be attached tonose cone 64, the shortening oftubular member 472 may result in the proximal shifting ofnose cone 64, which may reduce the possibility thatnose cone 64 may adversely impact the functioning of the heart (e.g., the left ventricle) during the intervention. -
FIGS. 31-32 illustrate an exampleouter sheath 512 that may be used with any of the systems disclosed herein. In this embodiments,sheath 512 includes a deflectabledistal region 578 that is configured to shift between a tapered (e.g., deflected radially inward) configuration as shown inFIG. 31 and an open configuration as shown inFIG. 32 . In at least some embodiments, the use ofouter sheath 512 may allow the use of aguidewire tube extension 572 lacking a nose cone (e.g., similar to what is shown inFIG. 28 ). Shiftingdistal region 578 between the tapered configuration and the open configuration may be achieved by proximally retractingouter sheath 512. In doing so,outer sheath 512 may deflect radially outward (e.g., when interacting with other components of the system) in order to allow implant 16 (not shown inFIGS. 31-32 ) to be implanted. - The materials that can be used for the various components of system 10 (and/or other systems disclosed herein) and the various tubular members disclosed herein may include those commonly associated with medical devices. For simplicity purposes, the following discussion makes reference to
outer sheath 12 and/orinner catheter 14. However, this is not intended to limit the devices and methods described herein, as the discussion may be applied to other similar tubular members and/or components of tubular members or devices disclosed herein. -
Outer sheath 12 and/orinner catheter 14 may be made from a metal, metal alloy, polymer (some examples of which are disclosed below), a metal-polymer composite, ceramics, combinations thereof, and the like, or other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic and/or super-elastic nitinol; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: NO6625 such as INCONEL® 625, UNS: NO6022 such as HASTELLOY® C-22®, UNS: N10276 such as HASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copper alloys (e.g., UNS: NO4400 such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g., UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, and the like; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like); platinum enriched stainless steel; titanium; combinations thereof; and the like; or any other suitable material. - As alluded to herein, within the family of commercially available nickel-titanium or nitinol alloys, is a category designated “linear elastic” or “non-super-elastic” which, although may be similar in chemistry to conventional shape memory and super elastic varieties, may exhibit distinct and useful mechanical properties. Linear elastic and/or non-super-elastic nitinol may be distinguished from super elastic nitinol in that the linear elastic and/or non-super-elastic nitinol does not display a substantial “superelastic plateau” or “flag region” in its stress/strain curve like super elastic nitinol does. Instead, in the linear elastic and/or non-super-elastic nitinol, as recoverable strain increases, the stress continues to increase in a substantially linear, or a somewhat, but not necessarily entirely linear relationship until plastic deformation begins or at least in a relationship that is more linear that the super elastic plateau and/or flag region that may be seen with super elastic nitinol. Thus, for the purposes of this disclosure linear elastic and/or non-super-elastic nitinol may also be termed “substantially” linear elastic and/or non-super-elastic nitinol.
- In some cases, linear elastic and/or non-super-elastic nitinol may also be distinguishable from super elastic nitinol in that linear elastic and/or non-super-elastic nitinol may accept up to about 2-5% strain while remaining substantially elastic (e.g., before plastically deforming) whereas super elastic nitinol may accept up to about 8% strain before plastically deforming. Both of these materials can be distinguished from other linear elastic materials such as stainless steel (that can also can be distinguished based on its composition), which may accept only about 0.2 to 0.44 percent strain before plastically deforming.
- In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy is an alloy that does not show any martensite/austenite phase changes that are detectable by differential scanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA) analysis over a large temperature range. For example, in some embodiments, there may be no martensite/austenite phase changes detectable by DSC and DMTA analysis in the range of about −60 degrees Celsius (° C.) to about 120° C. in the linear elastic and/or non-super-elastic nickel-titanium alloy. The mechanical bending properties of such material may therefore be generally inert to the effect of temperature over this very broad range of temperature. In some embodiments, the mechanical bending properties of the linear elastic and/or non-super-elastic nickel-titanium alloy at ambient or room temperature are substantially the same as the mechanical properties at body temperature, for example, in that they do not display a super-elastic plateau and/or flag region. In other words, across a broad temperature range, the linear elastic and/or non-super-elastic nickel-titanium alloy maintains its linear elastic and/or non-super-elastic characteristics and/or properties.
- In some embodiments, the linear elastic and/or non-super-elastic nickel-titanium alloy may be in the range of about 50 to about 60 weight percent nickel, with the remainder being essentially titanium. In some embodiments, the composition is in the range of about 54 to about 57 weight percent nickel. One example of a suitable nickel-titanium alloy is FHP-NT alloy commercially available from Furukawa Techno Material Co. of Kanagawa, Japan. Some examples of nickel titanium alloys are disclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which are incorporated herein by reference. Other suitable materials may include ULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available from Toyota). In some other embodiments, a superelastic alloy, for example a superelastic nitinol can be used to achieve desired properties.
- In at least some embodiments, portions or all of
outer sheath 12 andinner catheter 14 may also be doped with, made of, or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user ofsystem 10 in determining its location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloy, polymer material loaded with a radiopaque filler, and the like. Additionally, other radiopaque marker bands and/or coils may also be incorporated into the design ofsystem 10 to achieve the same result. - In some embodiments, a degree of Magnetic Resonance Imaging (MRI) compatibility is imparted into
system 10. For example,outer sheath 12 andinner catheter 14, or portions thereof, may be made of a material that does not substantially distort the image and create substantial artifacts (i.e., gaps in the image). Certain ferromagnetic materials, for example, may not be suitable because they may create artifacts in an MRI image.Outer sheath 12 andinner catheter 14, or portions thereof, may also be made from a material that the MRI machine can image. Some materials that exhibit these characteristics include, for example, tungsten, cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®, PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035 such as MP35-N® and the like), nitinol, and the like, and others. - A sheath or covering (not shown) may be disposed over portions or all of
outer sheath 12 andinner catheter 14 that may define a generally smooth outer surface forsystem 10. In other embodiments, however, such a sheath or covering may be absent from a portion of all ofsystem 10, such thatouter sheath 12 andinner catheter 14 may form an outer surface. The sheath may be made from a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane (for example, Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS 50A), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like. In some embodiments the sheath can be blended with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP. - In some embodiments, the exterior surface of the system 10 (including, for example, the exterior surface of
outer sheath 12 and inner catheter 14) may be sandblasted, beadblasted, sodium bicarbonate-blasted, electropolished, etc. In these as well as in some other embodiments, a coating, for example a lubricious, a hydrophilic, a protective, or other type of coating may be applied over portions or all of the sheath, or in embodiments without a sheath over portion ofouter sheath 12 andinner catheter 14, or other portions ofsystem 10. Alternatively, the sheath may comprise a lubricious, hydrophilic, protective, or other type of coating. Hydrophobic coatings such as fluoropolymers provide a dry lubricity which improves device handling and device exchanges. Lubricious coatings improve steerability and improve lesion crossing capability. Suitable lubricious polymers are well known in the art and may include silicone and the like, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxy alkyl cellulosics, algins, saccharides, caprolactones, and the like, and mixtures and combinations thereof. Hydrophilic polymers may be blended among themselves or with formulated amounts of water insoluble compounds (including some polymers) to yield coatings with suitable lubricity, bonding, and solubility. Some other examples of such coatings and materials and methods used to create such coatings can be found in U.S. Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference. - The coating and/or sheath may be formed, for example, by coating, extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusing several segments end-to-end. The layer may have a uniform stiffness or a gradual reduction in stiffness from the proximal end to the distal end thereof. The gradual reduction in stiffness may be continuous as by ILC or may be stepped as by fusing together separate extruded tubular segments. The outer layer may be impregnated with a radiopaque filler material to facilitate radiographic visualization. Those skilled in the art will recognize that these materials can vary widely without deviating from the scope of the present invention.
- It should be understood that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps without exceeding the scope of the invention. This may include, to the extent that it is appropriate, the use of any of the features of one example embodiment being used in other embodiments. The invention's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (20)
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US13/714,860 US9277993B2 (en) | 2011-12-20 | 2012-12-14 | Medical device delivery systems |
EP12821084.6A EP2793749B1 (en) | 2011-12-20 | 2012-12-20 | Medical device delivery systems |
PCT/US2012/070795 WO2013096545A1 (en) | 2011-12-20 | 2012-12-20 | Medical device delivery systems |
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CN104125816A (en) | 2014-10-29 |
EP2793749B1 (en) | 2023-02-22 |
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